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The study aims to evaluate the effectiveness of intraoperative combination of ketamine and magnesium sulfate infusions on postoperative analgesia in patients undergoing open rhinoplasty.
Postoperative pain remains one of the most crucial factors affecting patient satisfaction. These symptoms can be distressing for the patient and it may lead to negative psychological implications.
Ketamine is a non-competitive N-Methyl D-Aspartate (NMDA) receptor antagonist that works by blocking the NMDA receptors in the central and peripheral nervous systems.
Magnesium sulfate is also an antagonist for NMDA receptor that has been evaluated in several studies and showed that Mg sulfate decreased consumption of postoperative opioids.
Ketamine and magnesium sulfate have different sites of action on NMDA receptors, so their combination may produce a synergistic effect on NMDA receptors, resulting in more control of postoperative pain and more sparing of consumption of opioids.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| KM Group | Experimental | Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr. |
|
| Control group | Placebo Comparator | Patients will receive saline 0.9% as a control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ketamine and Magnesium Sulfate | Drug | Patients will receive a bolus of 0.5 mg/kg of ketamine given over a period of ten minutes followed by a constant infusion of 0.25 mg/kg/hr and a bolus dose of 30 mg/kg of magnesium sulfate during a 10-minute period followed by a continuous infusion of 9 mg/kg/hr. |
| Measure | Description | Time Frame |
|---|---|---|
| Total morphine consumption | Rescue analgesia of morphine will be given as a 3 mg bolus if the numeric rating scale (NRS) > 3, to be repeated after 30 min if pain persists until the NRS < 4. | 24 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Time to the 1st rescue analgesia. | Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated). | 24 hours postoperatively |
| Degree of pain |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sarah A Afifi, MD | Contact | 0501035864 | Sarah606060@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ain Shams University | Recruiting | Cairo | 11591 | Egypt |
The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
After the end of study for one year.
The data will be available upon a reasonable request from the corresponding author.
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|
| Saline 0.9% | Drug | Patients will receive saline 0.9% as a control group. |
|
Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 6, 8, 12, 18, and 24 h postoperatively.
| 24 hours postoperatively |
| Heart rate | Heart rate will be recorded preoperatively and every 15 minutes till the end of surgery. | Till the end of surgery (Up to 2 hours) |
| Mean arterial pressure | Mean arterial pressure will be recorded preoperatively and every 15 minutes till the end of surgery. | Till the end of surgery (Up to 2 hours) |
| Degree of patient satisfaction | Degree of patient satisfaction will be assessed on a 5-point Likert scale patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied; 5, extremely satisfied) | 24 hours postoperatively |
| Incidence of adverse events. | Incidence of adverse events such as bradycardia, hypotension, nausea, vomiting, respiratory depression, hallucinations, nightmares, blurred vision, dizziness or any other complication. | 24 hours postoperatively |
| ID | Term |
|---|---|
| D007649 | Ketamine |
| D008278 | Magnesium Sulfate |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D017616 | Magnesium Compounds |
| D007287 | Inorganic Chemicals |
| D013431 | Sulfates |
| D013464 | Sulfuric Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D017670 | Sodium Compounds |
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